Development and Validation of the BVQ
1 other identifier
observational
250
1 country
1
Brief Summary
The main aim of this study is the development of the Beliefs about Ventilation Questionnaire (BVQ).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 5, 2016
CompletedFirst Posted
Study publicly available on registry
September 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedJuly 26, 2022
January 1, 2018
2.3 years
September 5, 2016
July 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in adherence NIV in COPD patients at 3, 6 and 12 months as measured by the Beliefs of Ventilation Questionnaire (BVQ)
Baseline + After 3, 6 and 12 months following the recruitment
Secondary Outcomes (3)
Feasibility and acceptability of the questionnaire (duration / missing data)
Baseline + After 3, 6 and 12 months following the recruitment
Reliability over time of the questionnaire
Baseline + After 3, 6 and 12 months following the recruitment
External construct validity (The World Health Organization Quality of Life (WHOQOL); hours of Non Invasive Ventilation (NIV) prescribed, effective and referred by patients)
Baseline + After 3, 6 and 12 months following the recruitment
Eligibility Criteria
People with obstructive or restrictive respiratory diseases
You may qualify if:
- Age ≥ 18 years old
- Indication to Non Invasive Ventilation (NIV), in three slots: \<4; \>4 e \<12; \<12 hours
- Outpatients or Inpatients
- Obstructive or restrictive reparatory disorder
- Voluntary agreement to be involved in the Study
You may not qualify if:
- Psychiatric Disorder
- Glasgow Coma Scale (CGS) \<14
- Pure Obstructive Sleep Apnea Syndrome (OSAS)
- Tracheostomy with Invasive Ventilation (TIV) o Invasive Ventilation (IV)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS Santa Maria Nascente, Fondazione Don Carlo Gnocchi
Milan, 20148, Italy
Related Publications (3)
Lopez-Campos JL, Jara-Palomares L, Munoz X, Bustamante V, Barreiro E. Lights and shadows of non-invasive mechanical ventilation for chronic obstructive pulmonary disease (COPD) exacerbations. Ann Thorac Med. 2015 Apr-Jun;10(2):87-93. doi: 10.4103/1817-1737.151440.
PMID: 25829958RESULTOzyilmaz E, Ugurlu AO, Nava S. Timing of noninvasive ventilation failure: causes, risk factors, and potential remedies. BMC Pulm Med. 2014 Feb 13;14:19. doi: 10.1186/1471-2466-14-19.
PMID: 24520952RESULTvan Boven JF, Chavannes NH, van der Molen T, Rutten-van Molken MP, Postma MJ, Vegter S. Clinical and economic impact of non-adherence in COPD: a systematic review. Respir Med. 2014 Jan;108(1):103-13. doi: 10.1016/j.rmed.2013.08.044. Epub 2013 Sep 11.
PMID: 24070566RESULT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2016
First Posted
September 9, 2016
Study Start
September 1, 2016
Primary Completion
December 31, 2018
Study Completion
March 31, 2020
Last Updated
July 26, 2022
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share